Reflex Sympathetic Dystrophy Clinical Trial
— AlgoMIROfficial title:
Efficacy and Safety of a Learning Program of Self- Rehabilitation Exercises by Mirror Therapy in the Complex Regional Pain Syndrome of the Upper Limb : a Multicentric Randomized Open Study.
Verified date | January 2021 |
Source | Centre Hospitalier Universitaire de Saint Etienne |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
AlgoMIR project born thanks to a meeting between pain professionals and re-education staff. The goal of this project is to develop and evaluate a program of learning with exercises by mirror therapy, that could be easily shared with paramedic teams and easily adapted to different handicaps. Researchers have chosen to select patients with re-education of the upper extremity to benefit from rehabilitation sessions either from physiotherapists present in their city, or of functional rehabilitation hospital units.
Status | Terminated |
Enrollment | 34 |
Est. completion date | June 6, 2019 |
Est. primary completion date | June 6, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Affiliation to Social Security - CRPS (complex regional pain syndrome) type I or II defined by the criteria of Bruehl (Table 1) - CRPS of the upper limb including the wrist and / or hand - CRPS post-surgical or post-traumatic - Average pain in the last 24 hours of intensity > = 30/100 on EVA (0 no pain, 100: worst pain imaginable ) - Evolution for over 3 months and less than 2 years - Patients taking a stable background therapy for 15 days and not having received the following treatments in the previous months : bisphosphonate cure, infiltration, Qutenza, ketamine infusions - Patients accepting a rehabilitation (physiotherapists or hospital units for patients included on Saint-Etienne and hospital units for patients included in Lyon and Saint- Vallier) Exclusion Criteria: - CRPS post stroke or drug - Adhesive capsulitis isolated - Cognitive or language difficulties preventing understanding instructions and / or a correct clinical evaluation - Patient who already received a rehabilitation program with the use of mirror therapy or other virtual reality technology - CRPS in connection with an accident caused by a third party for which a legal procedure is underway - Major Depressive Episode - Dissociative Disorders - Visually impaired patients |
Country | Name | City | State |
---|---|---|---|
France | MPR des Massues | Lyon | |
France | Consultation Douleur de la Mutualité de la Loire | Saint Etienne | |
France | MPR de l'Hôpital Drôme Nord | Saint Vallier | |
France | Centre médical de l'Argentière | St Etienne | |
France | Chu Saint Etienne | St Etienne |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire de Saint Etienne |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Compare the Visual Analogue Scale (EVA) of pain | Compare after 8 weeks the score of EVA of pain in the last 24 hours for patients who performed during 8 weeks :
a program of mirror therapy associated with the usual care (M+R) or the usual care without mirror therapy |
Week 8 |
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